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On February 10, 2025, the Thai Food and Drug Administration (FDA) released updated guidelines for submitting change notifications related to the addition or reduction of medical device items for non-in-vitro diagnostic (non-IVD) medical devices. These guidelines outline the required documentation for various types of change requests and took effect on January 15, 2025. Key Highlights […]

On January 30, 2025, the Thai Food and Drug Administration (Thai FDA) issued new Change Notification Guidelines for Notified and Licensed In Vitro Diagnostic (IVD) Medical Devices. These guidelines outline updated regulatory requirements and take effect from January 15, 2025. The full announcement is available on the Thai FDA Official Website (กองควบคุมเครื่องมือแพทย์) [in Thai]. Key

The Medical Device Control Division has introduced an updated Change Notification System for medical devices in Thailand, effective January 15, 2025. The newly issued guideline regulates the increase or decrease of medical device items within the same medical device group without affecting their category classification. This guideline has been published under the authority of the

The Thai Food and Drug Administration (Thai FDA) has amended its announcement regarding the importation of medical devices in quantities necessary for personal use, under Section 27(5) of the Medical Device Act B.E. 2551 (2008). The new draft, B.E. 2567 (2024), specifies conditions under which certain medical devices are exempt from requiring a medical certification

The Thai Food and Drug Administration (Thai FDA) has released new guidelines for medical device sellers operating in Thailand. Effective immediately, these guidelines outline the necessary steps for compliance with regulatory requirements, including obtaining a sale license where applicable. Key Steps for Medical Device Sellers Step 1: Determine Whether a Sale License is RequiredMedical device

On December 4, 2024, the Thai FDA announced revisions to the regulations governing medical device advertising. These updates, outlined in the “Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License Validity for Medical Device Advertising B.E. 2568 (2025)”, aim to enhance clarity and ensure alignment